Device Recall Fujifilm

2500.0312.00 and 2500.0312.01

Gastroenterology-Urology Devices

2

No

Nationwide US and Canada

Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). || For use in endoscopic procedures. Used to observe, record and capture images.

Serial Number: 26320119

Radiology Devices

2

No

Distributed in HI.

Aspire HD, Full Field Digital, System, x-Ray, Mammographic; || Model: FOR MS-1000. || A mammography system used for screening and diagnosis of breast cancer.

Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

Cardiovascular Devices

2

No

Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.

Fujifilm Synapse Cardiovascular I ProSolv CardioVascular || Synapse Cardiovascular v4.0.8 || Synapse Cardiovascular v4.0.8 SR1 || Intended Use: || Picture Archiving and Communication System || Computer, Diagnostic, Programmable

Part Numbers: 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D and 202B1230408E

Gastroenterology-Urology Devices

2

No

Nationwide US and Canada

Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681

Gastroenterology-Urology Devices

2

No

Distributed in the US and Canada.

Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.